findmyKOL
Clinical trialNCT04598958CompletedInterventional

A Multidisciplinary "Integrated Management Team to Improve Maternal-Child Outcomes (IMPROVE)" Intervention to Improve Maternal and Child Outcomes in Lesotho

SponsorElizabeth Glaser Pediatric AIDS FoundationEnrollment1,004Human Immunodeficiency Virus
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This study aims to improve maternal and child health (MCH) outcomes by implementing and evaluating a multidisciplinary "Integrated Management Team to Improve Maternal-Child Outcomes (IMPROVE)" intervention to increase MCH, antiretroviral therapy (ART), and HIV services uptake and retention in Lesotho. The proposed intervention will focus efforts to improve the effectiveness of existing village health workers (VHW) and HIV support organizations (Lesotho Network of AIDS Service Organizations \[LENASO\] and Mothers2Mothers \[M2M\]) based at the facility and coordination between the facility and community. The IMPROVE intervention includes: (1) Multidisciplinary integrated management teams to coordinate patient-focused and outcome-oriented PMTCT and MCH services; (2) Enhanced Positive Health, Dignity, and Prevention (PHDP)-focused counseling and skills-building training and job aids; and (3) Increased early community-based counseling and support for first (antenatal care clinic) ANC attendees with particular attention to HIV-positive women to minimize loss to follow-up. The study will be a cluster randomized design with facilities randomized to receive the IMPROVE intervention or routine services offering the national standard of care. A cohort of HIV-positive and HIV-negative pregnant women will be enrolled and prospectively followed every three months through pregnancy and until the participant's child reaches 24 months of age. The primary HIV objectives will be to evaluate the effect of the intervention on retention in HIV care, viral suppression, adherence to ART in HIV-positive women, and HIV retesting in HIV-negative women. The investigators will also assess the effect of the IMPROVE intervention on general MCH indices including antenatal care (ANC) attendance, facility delivery, family planning, and immunization coverage. Secondary objectives include evaluation of adherence self-efficacy (HIV positive) or prevention self-efficacy (HIV negative), depression and stigma as well as disclosure, knowledge of partner status, and identification of discordant couples in intervention versus control facilities. Analysis of the cost-effectiveness of the IMPROVE intervention will also be conducted. In addition, qualitative interviews and focus group discussions will be conducted with study women, health care workers (HCW), LENASO, and VHWs to evaluate the feasibility and acceptability of integrating this intervention into routine care.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

No facility list is in our current data snapshot for this study. The registry record on ClinicalTrials.gov ↗ carries any published locations. Why? →

Drugs studied

No drug or biological interventions are in our data for this study — it may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
27 Jul 2016
Primary completion
31 Jul 2019
Completion
30 Sept 2020
Last update posted
22 Oct 2020
Registered enrollment
1,004
Registry id
NCT04598958

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.